When I think about the phrase “patient-centricity,” I often pause. It’s everywhere in our industry: clinical trial brochures, conference panels, even corporate mission statements. But too often, it risks becoming a buzzword rather than a lived reality.
In our latest Inside the Trends vodcast episode with Dr. Sarju Ganatra , a cardiologist and Co-Director of the Lahey Innovation Hub, we stripped patient-centricity back to its core. What does it actually mean at the point of care, where patients and clinicians are making real decisions every day? What surfaced was both sobering and inspiring: if we want trials to be patient-centric, they must first feel like a natural extension of care, not a disruption.
Moving Beyond Checklists
It’s tempting to reduce patient-centricity to checkboxes: free parking vouchers, shorter site visits, or digital consent forms. These are nice-to-have improvements, but they don’t touch the heart of the matter.
As Dr. Ganatra explained, true patient-centricity is designing research that patients can realistically participate in, without it being a burden, and that clinicians can deliver without derailing care. That means aligning trials with existing care pathways, respecting patients’ life circumstances, and acknowledging that no patient comes with just one condition in isolation.
This is the real work. Ensuring trial participation doesn’t just look good on paper, but actually fits into the messy, complicated, human lives of patients.
Expanding Access with Pragmatic and Decentralized Trials
Two models stand out as crucial for making trials more representative and relevant: pragmatic trials and decentralized trials.
Pragmatic trials loosen rigid eligibility criteria and reflect the diversity of real-world patient populations. Instead of designing for a hypothetical “ideal patient,” they embrace the complexity of comorbidities, social determinants of health (SDOH), and the realities of treatment pathways.
Decentralized trials take this further by moving research closer to the patient. Care can happen through local labs, pharmacies, telehealth, or even at home. Done well, this approach removes barriers that have historically excluded patients based on geography or access.
But there’s a critical caveat. Decentralization isn’t a plug-and-play solution. It introduces operational complexity, oversight challenges, and the need for integration into existing workflows. Without careful planning and strong collaboration between sponsors, providers, and regulators, decentralization risks shifting burdens rather than easing them.
The Wearables and AI Conundrum
If pragmatic and decentralized trials expand access, technology has the potential to supercharge them. Wearables and remote monitoring tools promise continuous, real-world data (RWD) streams. Artificial intelligence (AI) promises to sift through those mountains of data to separate signal from noise.
But as Dr. Ganatra pointed out, the reality inside the clinic is often overwhelming. Clinicians are already inundated with wearable-generated metrics (e.g., step counts, heart rhythms, oxygen saturation trends) that are not always actionable. For patients, the barrage of alerts can be stressful and even counterproductive.
The problem isn’t the data itself; it’s the lack of context. A heart rate spike at 3 a.m. may mean nothing more than a trip to the bathroom, yet it triggers an alert that disturbs both patient and provider.
Here’s where AI, particularly agentic AI, could be transformative. Instead of functioning as a simple threshold-based system, AI could act as a co-pilot by triaging data, contextualizing anomalies, and flagging what truly matters. This would lighten the cognitive load for both patients and clinicians, allowing them to focus on decisions that improve care.
Still, as Dr. Ganatra reminded us, AI should not replace human judgment. Trust remains essential, and AI should be a triage tool, not a decision-maker.
The Three-Legged Stool of Clinical Trials
Dr. Ganatra described clinical research as a three-legged stool: sponsor, principal investigator, and patient. Remove one leg, and the stool collapses.
Too often, clinicians are brought in after protocols are finalized, when it’s too late to align the study design with real-world practice. The result? Overly burdensome protocols, unrealistic visit schedules, or endpoints that don’t matter to patients. Trials may succeed statistically but fail to translate into practice because they miss what really counts—better, longer, more livable patient lives.
Clinicians are the trust bridge between sponsor and patient. Patients don’t join trials because of glossy brochures; they join because their doctor looks them in the eye and says, “This trial could fit your care plan.” If sponsors want trials to succeed, clinicians must be engaged early and meaningfully.
Designing with Patient-Centricity from Day One
Perhaps the most powerful takeaway from our discussion was this: you can’t retrofit patient-centricity. It must be baked into the trial design from day one.
That means:
- Early collaboration with both patients and clinicians before protocols are set in stone.
- Leveraging RWD to ensure eligibility criteria reflect actual patient populations, not hypothetical ideals.
- Designing for representativeness and access, accounting for broadband, caregiver support, cultural sensitivities, and SDOH.
- Integrating patient-reported outcomes so trials measure not just clinical endpoints but quality of life.
Protocol amendments made midstream to add patient-centricity only delay progress. The better path is starting with the principle that every trial participant is, first and foremost, a human being navigating a care journey.
Patient-Centricity as a Clinical Principle
As we wrapped up our discussion, Dr. Ganatra said something that has stayed with me. Patient-centricity must be a clinical principle, not a marketing tagline.
That principle asks a simple but profound question. Would I recommend this trial to my own patient? If the answer is no, then no amount of free parking or slick digital tools can make it truly patient-centric.
For sponsors and biopharma leaders, this requires courage to involve clinicians early, to use RWD honestly, to embrace operational complexity where necessary, and to measure what truly matters to patients.
If we do this right, clinical trials will no longer feel like disruptions. They will become a natural extension of care, expanding access, improving representativeness, and ultimately accelerating better outcomes.
Access the full Inside the Trends vodcast episode for a deeper dive with Dr. Sarju Ganatra and uncover how true patient-centricity can become your next trial’s competitive edge.
The views expressed by Dr. Ganatra are his own and do not represent the official position of the Lahey Innovation Hub or any of its affiliates.
About Steve Kundrot
Steve is a technology and business leader with over 20 years of experience in clinical research, health analytics, consulting, and software development. As Chief Operating Officer, he oversees TriNetX’s core operational functions and leads the development of a unified product roadmap designed to revolutionize clinical research and accelerate drug development by optimizing clinical trial design, enhancing post-market safety, and delivering research-grade data and evidence that enable and expedite regulatory approvals.
About Dr. Sarju Ganatra
Dr. Ganatra is a cardiologist, researcher, and innovation leader whose work bridges clinical medicine, data science, and environmental sustainability. As Vice Chair for Research and Co-Director of the Lahey Innovation Hub, he advances transformative initiatives that integrate patient care, technology, and planetary health. His research portfolio spans cardio-oncology, cardio-metabolic, environmental determinants of health, and digital health solutions aimed at reimagining the future of healthcare delivery.